Clearance Summary
SMITH AND DAVIS PRESSURE THERAPY SYSTEM received FDA 510(k) clearance under submission number K913654, sponsored by Smith & Davis Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1991-11-22.
- Submission: K913654
- Applicant / Sponsor: Smith & Davis Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5160
- Decision date: 1991-11-22
Classification & Regulation
This clearance is catalogued under FDA product code INX and 21 CFR 890.5160, within the Physical Medicine review panel as a Class II device.